This is an archived document. The links are no longer being updated.
TB Notes 2, 2001
Updates from the Research and Evaluation Branch
New Treatment Trial for Latent TB Infection
The Tuberculosis Trials Consortium (TBTC) has launched Study 26,
an important and ambitious new Phase III clinical trial. Study 26
will evaluate the effectiveness and tolerability of 3 months of
weekly rifapentine and isoniazid (INH), directly-observed, versus
9 months of daily INH, self-supervised, for the treatment of latent
tuberculosis infection (LTBI) in high-risk patients. While 9 months
of INH is highly effective and inexpensive, its use is limited because
the long duration of therapy tends to discourage patient adherence.
Owing to this key limitation, alternative shorter regimens have
become a priority. However, concerns have been raised about the
short-course 2-month rifampin/ pyrazinamide (2RZ) regimen because
of safety and tolerability questions, drug-drug interactions, and
the large pill burden.
Rifapentine (RPT) offers considerable programmatic advantages over
rifampin owing to a pharmokinetic profile that allows once-weekly
dosing. Furthermore, animal studies suggest that RPT/INH is at least
equivalent to RZ or INH for treatment of LTBI.
Eligible study participants will be males and nonnursing, nonpregnant
females 12 years of age and older. Their reason or risk factor for
requiring treatment for LTBI should include one of the following:
close contact with a person with culture-positive TB; documented
recent PPD conversion; HIV-seropositivity with PPD ³5 mm; or
pulmonary parenchymal fibrosis on chest x-ray and PPD ³5 mm.
Patients will be followed for 2 years after completion of therapy
for evidence of active tuberculosis. With a sample size of 8,000,
this will be the largest clinical trial sponsored by the DTBE. The
24 sites of the TBTC started enrolling patients throughout the United
States and Canada on June 5, 2001, but it is expected that expansion
of TBTC capacity and international collaboration will be needed
to strengthen enrollment.
If a regimen of once-weekly 3RPT/INH is as effective and well-tolerated
as daily 9INH, 3RPT/INH would be considered a first-line regimen
for the treatment of latent M. tuberculosis infection.
It would be a key component to achieving the CDC goal of eliminating
TB in the United States. Elsa Villarino, MD, from the Research and
Evaluation Branch, DTBE, is the project officer of the study and
Timothy R. Sterling, MD, from Johns Hopkins School of Medicine and
the Baltimore City Health Department, is the protocol chair.
óReported by Sam (Judith) Hackman, RN,
Baltimore City Health Department
Johns Hopkins School of Medicine
Editorís note: Ms. Hackman is one of the two coordinators who are
part of the Study Protocol Team for Study 26. She is the study coordinator
for Johns Hopkins University; in addition, she writes and coordinates
the Study 26 newsletter.
Released October 2008
Centers for Disease Control and Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Division of Tuberculosis Elimination - http://www.cdc.gov/tb
Please send comments/suggestions/requests
CDC/Division of Tuberculosis Elimination
Communications, Education, and Behavioral Studies Branch
1600 Clifton Rd., NE - Mailstop E-10, Atlanta, GA 30333